Innovations in Hearing Accessibility and Technology (IHAT) Study

Summary

The research will explore outcomes of different service delivery models of over-the-counter (OTC) hearing aids by comparing them to prescription hearing aids fitted by specialists in individuals with mild to moderate hearing loss. The investigators will examine how each type affects users' experiences, behavior, thinking skills, and brain activity related to hearing. Additionally, the study will focus on what types of people prefer each hearing aid option, what helps or hinders these choices, and compare the costs of four different service options. This approach will help transition from research findings into real-world practice, providing useful information for healthcare providers and policymakers about OTC hearing aid options.

Conditions

• Hearing Loss
• Hearing Aids
• OTC Hearing Aids

Interventions

DEVICE

HA-HCP

Prescription hearing aid fit by a hearing healthcare professional using audiology best practices.

DEVICE

OTC-HCP

Over-the-counter hearing aids fit by a hearing care professional using audiology best practices.

DEVICE

OTC-R

OTC fit to an individual using some best practices via remote consultation.

DEVICE

OTC-SF

Self-fit OTC hearing aids without any clinical support from HCPs.

Sponsors & Collaborators

• National Institute on Deafness and Other Communication Disorders (NIDCD)

  collaborator NIH

• University of Colorado, Denver

  lead OTHER

Principal Investigators

• Vinaya Manchaiah, AuD, MBA, PhD · University of Colorado, Denver

• Anu Sharma, PhD · University of Colorado, Boulder

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

40 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-11-13

Primary Completion

2028-12-31

Completion

2029-03-31

FDA Device

Yes

Countries

• United States

Study Locations